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« Court Report | Main | The Tragedy of a Bad Idea »

August 24, 2009


This is the best review ever on the Follow-on Biologic Drugs I come across with.
Thank you Dr. Grabowski's.

Well, well, well. The snakes who provided the arguments against Hatch-Waxman...often false data, not peer reviewed and frequently with Big Pharma financing, covert and overt...are coming out of their holes to spread their poison again. Please research his background properly. Biotech products have enjoyed virtual perpetual patents depriving the world of access to these remarkable medicines. At least twenty-five generic companies can produce geneic biotech medicines that will act in the body with the same results as the brand biotech. Once again science is trumped by politics. Over the next decade generic biotech could dramatically help close the cost gap of reforming the delivery of medical services including pharmaceuticals. Senator Hatch and others have said that Hatch-Waxman reduce the cost of medicine ten billion dollars a year or $230 billion since its enactment. Over the decade generic biotech can provide twice that amount in biotech savings if generics are permitted to enter the market rationally and without politics hiding profits...and campaign contribuions. The American people...and suffering people througout the world...deserve better.

bill haddad

(I initiated and negotiated "Hatch-Waxman" as head of the generic trade association. That legislation, after thirty-five years of opposition, finally opened the door to generic competition when patents legally expired. I was a generic manucaturer in the US and overseas. I inroduced generic biotech to the US almost a decade ago and remain commercially involved in the process today).

Bill, Bill, Bill:

"Snakes," "not peer reviewed," "false data" (an interesting oxymoron), "coming out of their holes" - exactly how does this invective move the debate forward?

One of the reasons for extracting the assumptions behind Professor Grabowski's analysis is to prompt those who disagree with him to challenge the assumptions, to tell us all why he is wrong. You haven't done that.

Your point about the number of generic companies that could replicate (reliably and safely) biologic drugs is contrary to what the FTC thinks, who have argued for NO data exclusivity for follow-on biologic drugs because traditional generic companies won't be able to enter the space. It also flies in the face of the differences in complexity of the molecules and what is required to make them commercially, all of which is freely-available data from existing biopharma companies. And, most importantly, these issues are not part of Professor Grabowski's analysis - he doesn't make any reference to the safety issues that may arise for follow-on biologics.

Right now, the data exclusivity period for biologic drugs is infinity - since there isn't one. The politics you bemoan is actually from politicians who believe that "making a stand" for saving the most money for the Federal government - the biggest winner in any follow-on biologics regime - is more important than making the reasonable compromise now (because, by Professor Grabowski's calculus, 12 years of data exclusivity is insufficient, but it's what the innovator biopharma industry will support) and seeing what happens. If 12 years is too long, Congress can amend the statute to reduce it, based on actual data rather than various forms of crystal-ball gazing. But if it is too short, it will be very hard to get that genie back in the bottle. And if that inhibits innovation, we all suffer.

If you, or anyone, can challenge the assumptions from Professor Grabowski's peer-reviewed paper, please do so.

Thanks for the comment.

Haddad’s comment is laughable. Because of the difficulty of making biotech products, I predict very few traditional generic companies will ever enter the biogeneric space.

Yes the challenges are many for generic companies....Thanks to Prof. Grabowski's Analysis.

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